Stakeholders' Perspectives on Current Issues in Data Monitoring Committees.
benefit‐risk
data monitoring committee
patient safety
study integrity
Journal
Biometrical journal. Biometrische Zeitschrift
ISSN: 1521-4036
Titre abrégé: Biom J
Pays: Germany
ID NLM: 7708048
Informations de publication
Date de publication:
Oct 2024
Oct 2024
Historique:
revised:
10
05
2024
received:
15
12
2023
accepted:
11
08
2024
medline:
23
9
2024
pubmed:
23
9
2024
entrez:
23
9
2024
Statut:
ppublish
Résumé
Data Monitoring Committees (DMCs) are groups of experts that review accumulating data from one or more ongoing clinical studies and advise the Sponsor regarding the continuing safety of study subjects along with the continuing validity and scientific merit of the study. Although DMCs are widely used, considerable variability exists in their conduct. This paper offers recommendations, derived from sessions given at the 2023 Central European Network International Biometric and Statisticians in the Pharmaceutical Industry Conferences' and the authors' experiences. We focus on four topics that are part of the DMC process and where there is unclarity and inconsistency in current practices: (1) Communication with the DMC-We reflect on the importance of effective, proper communication channels between the DMC and relevant stakeholders to foster collaboration and exchange of critical information while retaining study integrity throughout. (2) Open sessions-We discuss the benefits of incorporating open sessions in DMC meetings to enhance transparency, inclusivity, and the consideration of diverse perspectives, as well as pitfalls of open sessions. (3) Access to efficacy data-We highlight the need for appropriate access to efficacy data by DMCs and discuss how to implement this in practice and how to address potential concerns regarding multiplicity. (4) Interactive data displays-We outline the utilization of interactive data displays to facilitate a more intuitive understanding of study results by the DMC. By addressing these topics, we aim to provide comprehensive practical recommendations that bridge the gap between current practices and optimal DMC functionality.
Identifiants
pubmed: 39308116
doi: 10.1002/bimj.202300384
doi:
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
e202300384Informations de copyright
© 2024 Wiley‐VCH GmbH.
Références
Buhr, K. A., M. Downs, J. Rhorer, R. Bechhofer, and J. Wittes. 2018. “Reports to Independent Data Monitoring Committees.” Therapeutic Innovation & Regulatory Science 52, no. 4: 459–468. https://doi.org/10.1177/2168479017739268.
Calis, K. A., P. Archdecon, R. Bain, et al. 2017. “Recommendations for Data Monitoring Committees From the Clinical Trials Transformation Initiative.” Clinical Trials 14, no. 4: 342–348. https://doi.org/10.1177/1740774517707743.
DeMets, D. L., and S. S. Ellenberg. 2016. “Data Monitoring Committees—Expect the Unexpected.” New England Journal of Medicine 375, no. 14: 1365–1371. https://doi.org/10.1056/NEJMra1510066.
Ellenberg, S. S., T. R. Fleming, and D. L. DeMets. 2002. Data Monitoring Committees in Clinical Trials. Hoboken, NJ: John Wiley & Sons Ltd. https://doi.org/10.1002/0470854162.
European Medicines Agency. 2006. “Guideline on Data Monitoring Committees.” European Medicines Agency. Last modified January 1, 2006. https://www.ema.europa.eu/en/data‐monitoring‐committees‐scientific‐guideline.
European Medicines Agency. 2020. “Questions and Answers on Data Monitoring Committees Issues.” European Medicines Agency. Last modified October 10, 2020. https://www.ema.europa.eu/en/data‐monitoring‐committees‐issues‐scientific‐guideline.
Evans, S. R. 2022. “Independent Oversight of Clinical Trials Through Data and Safety Monitoring Boards.” NEJM Evidence 1, no. 1: EVIDctw2100005. https://doi.org/10.1056/evidctw2100005.
Evans, S. R., R. Bigelow, C. Chuang‐Stein, et al. 2020. “Presenting Risks and Benefits: Helping the Data Monitoring Committee Do Its Job.” Annals of Internal Medicine 172, no. 2: 119–125. https://doi.org/10.7326/M19‐1491.
Evans, S. R., L. Zeng, and W. Dai. 2023. “The Data and Safety Monitoring Board: The Toughest Job in Clinical Trials.” NEJM Evidence 2, no. 2: EVIDctw2200220. https://doi.org/10.1056/evidctw2200220.
Fleming, T. R., D. L. DeMets, M. T. Roe, et al. 2017. “Data Monitoring Committees: Promoting Best Practices to Address Emerging Challenges.” Clinical Trials: Journal of the Society for Clinical Trials 14, no. 2: 115–123. https://doi.org/10.1177/1740774516688915.
Fleming, T. R., S. S. Ellenberg, and D. L. DeMets. 2018. “Data Monitoring Committees: Current Issues.” Clinical Trials 15, no. 4: 321–328. https://doi.org/10.1177/1740774518764855.
Fleming, T. R., C. H. Hennekens, M. A. Pfeffer, and D. L. DeMets. 2014. “Enhancing Trial Integrity by Protecting the Independence of Data.” Journal of Biopharmaceutical Statistics 24, no. 5: 968–975. https://doi.org/10.1080/10543406.2014.925719.
Gallo, P., and S. Roychoudhury. 2023. “Challenges in Implementing Futility Schemes, With Reference to Aducanumab.” Therapeutic Innovation & Regulatory Science 57, no. 3: 515–520. https://doi.org/10.1007/s43441‐023‐00499‐0.
Grant, A. M., D. G. Altman, A. B. Babiker, et al. 2005. “Issues in Data Monitoring and Interim Analysis of Trials.” Health Technology Assessment 9, no. 7: 1–238. https://doi.org/10.3310/hta9070.
Herson, J. 2016. Data and Safety Monitoring Committees in Clinical Trials. New York: Chapman & Hall. https://doi.org/10.1201/9781315181608.
Lewis, R. J., K. A. Calis, and D. L. DeMets. 2016. “Enhancing the Scientific Integrity and Safety of Clinical Trials.” JAMA 316, no. 22: 2359–2360. https://doi.org/10.1001/jama.2016.16070.
Mütze, T., and T. Friede. 2020. “Data Monitoring Committees for Clinical Trials Evaluating Treatments of COVID‐19.” Contemporary Clinical Trials 98: 106154. https://doi.org/10.1016/j.cct.2020.106154.
Neaton, J. D., B. Grund, and D. Wentworth. 2018. “How to Construct an Optimal Interim Report: What the Data Monitoring Committee Does and Doesn't Need to Know.” Clinical Trials 15, no. 4: 359–365. https://doi.org/10.1177/1740774518764449.
Pharmaceuticals and Medical Devices Agency. 2013. “Guideline on Data Monitoring Committee.” Guideline on Data Monitoring Committee. Last modified April 4, 2013. www.pmda.go.jp/files/000232300.pdf.
Pocock, S. J. 2004. “A Major Trial Needs Three Statisticians: Why, How and Who?” Statistics in Medicine 23, no. 10: 1535–1539. https://doi.org/10.1002/sim.1791.
Shneiderman, B. 1996. “The Eyes Have It: A Task by Data Type Taxonomy of Information Visualizations.” In Proceedings 1996 IEEE Symposium on Visual Languages, 336–343. Piscataway, NJ: IEEE. https://doi.org/10.1109/VL.1996.545291.
Swedberg, K., J. S. Borer, B. Pitt, S. Pocock, and J. Rouleau. 2016. “Challenges to Data Monitoring Committees When Regulatory Authorities Intervene.” The New England Journal of Medicine 374, no. 16: 1580–1584. https://doi.org/10.1056/NEJMsb1601674.
U.S. Food and Drug Administration. 2006. “Guidance for Clinical Trial Sponsors—Establishment and Operation of Clinical Trial Data Monitoring Committees, FDA CBER, CDER + CDRH.” U.S. Food and Drug Administration. Last modified March 2006. https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/establishment‐and‐operation‐clinical‐trial‐data‐monitoring‐committees.
U.S. Food and Drug Administration. 2024. “Use of Data Monitoring Committees in Clinical Trials.” U.S. Food and Drug Administration. Last modified February 2024. https://www.fda.gov/regulatory‐information/search‐fda‐guidance‐documents/use‐data‐monitoring‐committees‐clinical‐trials.
UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. 2005. “Operational Guidelines for the Establishment and Functioning of Data and Safety Monitoring Boards.” World Health Organization. Last modified 2005. https://iris.who.int/handle/10665/69171.
Vandemeulebroecke, M., M. Baillie, A. Mirshani, and E. Lesaffre. 2023. “DMC Reports in the 21st Century: Towards Better Tools for Decision‐Making.” Trials 24, no. 1: 289. https://doi.org/10.1186/s13063‐023‐07290‐4.
Wang, W., R. Revis, M. Nilsson, and B. Crowe. 2021. “Clinical Trial Drug Safety Assessment With Interactive Visual Analytics.” Statistics in Biopharmaceutical Research 13, no. 3: 355–366. https://doi.org/10.1080/19466315.2020.1736142.
Wildfire, J., R. Bailey, R. Z. Krouse, et al. 2018. “The Safety Explorer Suite: Interactive Safety Monitoring for Clinical Trials.” Therapeutic Innovation & Regulatory Science 52, no. 6: 696–700. https://doi.org/10.1177/2168479018754846.